NCT01526577

Brief Summary

This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 13, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

January 20, 2012

Results QC Date

May 20, 2015

Last Update Submit

November 3, 2017

Conditions

Acute Coronary Syndrome

Keywords

phase1healthy subjectsantiplatelet agent

Outcome Measures

Primary Outcomes (3)

  • Adverse Events of LC23-1306

    7 days (plus or minus 1 day)

  • Pharmacodynamic Measurement

    Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test. \* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section.

    1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study

  • Platelet Aggregation Test, Bleeding Test

    pre-dose, up to 1 day post-dose

Secondary Outcomes (1)

  • AUC

    pre-dose, up to 3 days post-dose

Study Arms (3)

LC23-1306

EXPERIMENTAL

experimental drug

Drug: LC23-1306

placebo

PLACEBO COMPARATOR

LC23-1306 placebo

Drug: placebo

Ticagrelor

ACTIVE COMPARATOR

active comparator

Drug: Ticagrelor

Interventions

LC23-1306DRUG

LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg

Also known as: antiplatelet agent
LC23-1306
placeboDRUG

LC23-1306 placebo

placebo
TicagrelorDRUG

Ticagrelor 90mg

Ticagrelor

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects between the ages of 20 and 50 years at screening
  • Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}2.
  • Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
  • Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Platelet Aggregation InhibitorsTicagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Dong Yeop Shin
Organization
LG Life Sciences
dongyeopshin@lgls.com
82 2 6924 3114

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

February 6, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

August 1, 2013

Last Updated

August 13, 2018

Results First Posted

August 13, 2018

Record last verified: 2013-08

Locations

KR(1)